CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM

K100599 · Orthosoft, Inc. · OLO · Apr 5, 2010 · Neurology

Device Facts

• Record ID: K100599
• Device Name: CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM
• Applicant: Orthosoft, Inc.
• Product Code: OLO · Neurology
• Decision Date: Apr 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

CAS Fixation Pins from Zimmer CAS are intended for use as temporary bone fixation pins to attach orthopedic surgical instruments to bones in order to allow referencing their relative locations as required in the use of computer assisted surgery systems. Their specific uses and indications including their method of use and attachment sites are as specified in the computer assisted surgery system that involves their use.

Device Story

CAS Fixation Pins are threaded bone pins, similar to Steinmann pins, used to temporarily fixate locational reference instruments to bone. These pins serve as physical anchors for tracking arrays in computer-assisted surgery (CAS) systems. The device is used in an operating room setting by surgeons or trained surgical staff. The pins provide a stable reference point, allowing the CAS system to track the spatial position of bones during orthopedic procedures. This tracking data is used by the CAS system to provide real-time navigation or guidance to the surgeon, potentially improving the accuracy of instrument placement or bone resection. The pins are provided sterile for single-use.

Clinical Evidence

No clinical data; bench testing only. Sterilization and packaging validation performed to ensure SAL of 10^-6.

Technological Characteristics

Threaded bone pins similar to Steinmann pins. Provided sterile. Sterilization method: validated process (SAL 10^-6).

Indications for Use

Indicated for temporary bone fixation to attach orthopedic surgical instruments to bones for referencing relative locations during computer-assisted surgery. Patient population and specific attachment sites are defined by the associated computer-assisted surgery system.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• Navitrack System – Partial Hip Resurfacing Universal from Zimmer CAS (K071929)

Submission Summary (Full Text)

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# 4100599 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS CAS Fixation Pins

Applicant: Zimmer CAS 75 Queen Street, suite 3300 Montreal. Quebec Canada. H3C 2N6 Tel .: [phone] Fax: [phone]

APR - 5 2010

Contact Person: Christopher McLean

Date Summary Prepared: March 1, 2010

Device Trade Name: CAS Fixation Pins

Device Classification Name: Stereotaxic Instrument (84 HAW); 21 CFR § 882.4560

#### Predicate Device:

Navitrack System – Partial Hip Resurfacing Universal from Zimmer CAS (transferred from Orthosoft Inc.), 510(k) # K071929 -

#### Device Description:

CAS Fixation Pins are threaded bone pins similar to Steinmann pins. They are used to temporarily fixate locational reference instruments to bones in order to reference their location in Computer Assisted Surgery (CAS) systems.

#### Indications for Use / Intended Use:

CAS Fixation Pins from Zimmer CAS are intended for use as temporary bone fixation pins to attach orthopedic surgical instruments to bones in order to allow referencing their relative locations as required in the use of computer assisted surgery systems. Their specific uses and indications including their method of use and attachment sites are as specified in the computer assisted surgery system that involves their use.

#### Technological Comparisons to the Predicates:

The difference between the proposed and predicate pins is that the proposed pins will be provided sterile packaged while the predicate ones are provided non-sterile to be sterilized by the user facility. The proposed method of sterilization while the labeled user method for the predicate is the common steam sterilization cycle used in hospital settings. The proposed and predicate pins are otherwise identical.

#### Performance Data:

The proposed pin will be provided sterile using validated sterilization and packaging methods with an SAL of 10-9.

#### Conclusion:

The information and data provided in this 510(k) Premarket Notification established that the proposed CAS Fixation Pins are substantially equivalent to the fixation pins of the predicate.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

APR - 5 2010

Zimmer CAS % Mr. Christopher McLean Associate Director Quality & Regulatory Affairs 75 Queen Street, Suite 3300 Montreal, Quebec, Canada H3C 2N6

Re: K100599

Trade/Device Name: CAS Fixation Pins Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: March 01, 2010 Received: March 03, 2010

Dear Mr. McLean:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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### Page 2 - Mr. Christopher McLean

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### K 100599 510(k) Number:

Device Name: CAS Fixation Pins

#### Indications for Use.

CAS Fixation Pins from Zimmer CAS are intended for use as temporary bone fixation pins to attach orthopedic surgical instruments to bones in order to allow referencing their relative locations as required in the use of computer assisted surgery systems. Their specific uses and indications including their method of use and attachment sites are as specified in the computer assisted surgery system that involves their use.

Prescription Use (per 21CFR 801.109) Over-the-Counter Use

## Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Nil R. Dd
(Division Sign-Off)

for msm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100599